Efficacy and safety of adalimumab in Chinese adults with active ankylosing spondylitis: results of a randomised, controlled trial
- Feng Huang1,
- Jieruo Gu2,
- Ping Zhu3,
- Chunde Bao4,
- Jianhua Xu5,
- Huji Xu6,
- Huaxiang Wu7,
- Guochun Wang8,
- Qun Shi9,
- Nupun Andhivarothai10,
- Jaclyn Anderson10,
- Aileen L Pangan10
- 1Department of Rheumatology, Chinese PLA General Hospital, Beijing, People's Republic of China
- 2Department of Rheumatology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China
- 3Department of Rheumatology, Xijing Hospital of Fourth Military Medical University, Xi'an, People's Republic of China
- 4Department of Rheumatology, Renji Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China
- 5Department of Rheumatology, First Affiliated Hospital of Anhui Medical University, Hefei, People's Republic of China
- 6Department of Rheumatology, Changzheng Hospital of Second Military Medical University, Shanghai, People's Republic of China
- 7Department of Rheumatology, Second Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, People's Republic of China
- 8Department of Rheumatology, China-Japan Friendship Hospital, Beijing, People's Republic of China
- 9Department of Rheumatology, Peking Union Medical College Hospital, Beijing, People's Republic of China
- 10AbbVie Inc, North Chicago, IL,USA
- Correspondence to Dr Feng Huang, Department of Rheumatology, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, People's Republic of China;
- Received 20 August 2012
- Revised 21 December 2012
- Accepted 3 February 2013
- Published Online First 8 March 2013
Background and objectives Efficacy of adalimumab for ankylosing spondylitis (AS) has been established for Western populations but not in the Chinese population. This study is the first to evaluate the efficacy and safety of adalimumab in Chinese patients with AS.
Methods Chinese adults with active AS who had an inadequate response or were intolerant to ≥1 non-steroidal anti-inflammatory drugs were randomised to adalimumab 40 mg (N=229) or matching placebo (N=115) subcutaneously every other week (EOW) for 12 weeks, followed by a 12-week open-label adalimumab 40 mg EOW phase. The primary efficacy endpoint was the percentage of patients meeting the Assessment in Spondyloarthritis International Society (ASAS20) response criteria at week 12. The recently developed AS Disease Activity Score (ASDAS), as well as efficacy measures of spinal mobility, disease activity, physical function and quality of life were evaluated.
Results At week 12, adalimumab treatment resulted in a significantly greater percentage of ASAS20 responders than placebo (67.2% versus 30.4%, respectively; p<0.001). Differences in ASAS20 were observed as early as week 2 (42.8% vs 6.1%, respectively; p<0.001). The percentages of patients achieving ASAS40, ASAS 5/6 and ASDAS inactive disease were significantly greater with adalimumab than placebo at week 12 (all p<0.001). Tuberculosis was reported in one patient. No cases of malignancy, lymphoma, demyelinating disease or lupus-like syndrome were reported during the study.
Conclusions Adalimumab significantly reduced the signs and symptoms, improved physical function and quality of life of Chinese patients with active AS, and was generally safe and well tolerated in this population.